Medical Device Manufacturing Engineer (Capital Equipment)

IPG Photonics; Marlborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

IPG Photonics is looking for a Manufacturing Engineer to support the manufacture and service of medical devices. This role includes responsibilities such as organizing production workflows, developing tooling, ensuring compliance with regulatory standards, and conducting training. The ideal candidate has a Bachelor of Science in a technical discipline, 3-5+ years of experience in the medical device field, and proficiency in relevant test equipment and ERP systems. Knowledge of the Russian language is a plus.

Qualifications

• 3-5+ years of experience in manufacturing medical device equipment.
• Knowledge of U.S. and global regulatory requirements for medical devices.
• Experience with disposable medical devices is a plus.

Responsibilities

• Organize production workflow to maximize efficiency.
• Develop and review work instructions and test procedures.
• Conduct training for production and quality associates.

Skills

Project management

Regulatory compliance knowledge

Proficiency in test equipment

Knowledge of Russian language

Education

Bachelor of Science in a technical discipline

Tools

Microsoft Office applications

ERP systems

Test equipment (e.g., voltmeters, oscilloscopes)

Job description

Job Summary

The Manufacturing Engineer is responsible for supporting the manufacture and service of medical devices and disposables. This role focuses on production workflow optimization, documentation, tooling development, regulatory compliance, and cross‑functional collaboration to ensure efficient, compliant, and repeatable manufacturing operations.

This position is governed by the IPG Medical Corporation Quality Management System and applicable regulatory and quality standards.

Job Functions

• Organizes production workflow to maximize efficiency and contain total costs of assembly.
• Develops, approves, and reviews work instructions and test procedures to support standardized work in the production area.
• Develops and qualifies tooling to improve manufacturing process yield and reduce process variation.
• Conducts training for production and quality associates.
• Assists with planning, scheduling, and coordination of production activities to fulfill customer orders.
• Executes production process transactions using the ERP system.
• Ensures compliance of the production environment with cGMP, ISO, and all other applicable medical device standards and regulations.
• Initiates and executes disposition of Non‑Conforming Material Reports (NCMRs); assists with investigation of production‑related CAPAs.
• Works with engineering to feedback design issues and resolve them for future builds through the ECO system.
• Participates in new vendor qualification activities to improve supplier performance.
• Evaluates alternate sources for BOM components and makes recommendations to design engineering.
• Initiates process control improvements to support cost reduction and on‑time delivery objectives.
• Participates in service and repair of customer‑owned and remanufactured equipment.
• Develops and executes experiments to test new components and manufacturing processes prior to product use.

Requirements

Education

• Bachelor of Science degree in a technical discipline or equivalent work experience.
• Strong knowledge of U.S. and global regulatory requirements for medical devices.
• Solid project management skills.
• Knowledge of the Russian language is preferred but not required.

Experience

• 3-5+ years of experience in the manufacture and service of medical device equipment.
• Disposable medical device a plus.
• Laser experience a plus.
• Proficient in the use of test equipment such as digital voltmeters, oscilloscopes, and laboratory power supplies.
• Proficient with light manufacturing and assembly equipment, including PCB soldering stations and wire cutting/stripping tools.
• Working knowledge of ERP systems and Microsoft Office applications.